Venting devices

Surgery – Container for blood or body treating material – or means used...

Reexamination Certificate

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Details

C604S411000

Reexamination Certificate

active

06171293

ABSTRACT:

This invention relates to venting devices of the kind provided for venting the interior of a sealed container by passing the tip of a hollow needle through a sealing portion of the container.
In the laboratory testing of blood samples, it is conventional practice for the blood samples to be contained in blood culture bottles of standard type provided with self-sealing rubber stoppers. Samples of blood may be introduced into, and removed from, the bottles by passing the needle of a syringe through the stopper and either dispensing the blood sample from the syringe or drawing the blood sample into the syringe, the bottle being automatically resealed on withdrawal of the needle from the stopper. In certain laboratory tests, it is necessary for cultures to be grown aerobically, and this requires the introduction of air into the blood culture bottles. This may be achieved by injecting air through the bottle stopper using a conventional syringe, or alternatively by simply passing an open-ended hollow needle through the stopper to permit venting of the interior of the bottle.
WO 94/19451 discloses a venting device for a culture bottle in which a needle carrier is axially slidable in a guide tube so as to penetrate the bottle septum with the object of releasing pressure built up in the bottle due to organism growth. Such a device enables the asepticty of the needle to be maintained substantially right up to the moment of penetration of the bottle septum. The venting device is preferably in the form of a sterile package which is disposable after use.
Known methods of introducing air into such blood culture bottles suffer from a number of disadvantages in use. Firstly it is necessary for the needle to be replaced after puncturing of each bottle stopper in order to prevent cross-contamination between blood samples. Furthermore there is a danger that the operator will be accidentally pricked with the needle of the syringe on removal of the needle from the bottle stopper. As is well known, so-called “needle stick” can be highly dangerous due to the risk of transfer of blood-related diseases.
U.S. Pat. No. 4,507,118 discloses a fitment for an animal injection gun incorporating a collapsible sleeve and sterilising means at the end of the sleeve which serves to sterilise the tip of the needle of the injection gun during an injection so that a large number of animals can be injected using a single fitment without risk of cross-infection.
BRIEF DESCRIPTION OF THE INVENTION
It is an object of the invention to provide a venting device which overcomes one or more of these disadvantages.
According to the present invention there is provided a venting device for venting the interior of a sealed container by passing the tip of a hollow needle through a sealing portion of the container, the device comprising a collapsible shield for shielding the needle, a needle support in the vicinity of one end of the shield for holding the needle and incorporating a vent passage providing fluid communication between the hollow interior of the needle and the atmosphere, and sterilising means in the vicinity of the other end of the shield, the two ends of the shield being reciprocable relative to one another in the direction of the length of the needle, whereby, in use, when venting of the container is effected by placing said other end of the shield against the sealing portion with the shield in an extended condition and applying pressure to the device in a direction towards the sealing portion, the tip of the needle moves through the sterilising means and passes through the sealing portion to vent the container as the shield collapses under the applied pressure.
In use of such a venting device for venting of a blood culture bottle, the needle is sterilised and the venting operation is effected in a single movement, so that a large number of venting operations may be carried out in a short space of time. Optionally a plurality of such devices may be mounted in a jig permitting venting of a plurality of containers simultaneously, so as to render the device particularly easy to use in such a manner as to enable a large number of venting operations to be carried out whilst allowing sufficient time for the sterilising action to take place during the venting operation. Whilst the word “sterilising” is used in this specification in the sense of killing microorganisms, such as bacteria or viruses, it should be understood that it is not essential that all microorganisms are killed, that is to say that the needle is rendered absolutely sterile. Furthermore it is to be understood that the word “shield” includes arrangements in which the wall of the shield is either continuous or apertured (in which case the apertures may be in the form of slots extending from one end of the sleeve to the other).
Advantageously the vent passage incorporates a vent filter for cleaning of air passing along the vent passage.
Furthermore the vent passage may include an axial passage aligned with the needle and opening into a chamber, and a transverse passage extending from the chamber and opening to atmosphere at an outer surface of the device.
Preferably the shield is resiliently biased into its extended condition, for example by means of a spring within the shield, so that, on release of the applied pressure after venting of the container, the tip of the needle moves back through the sterilising means as the shield reassumes its extended condition.
Furthermore the sterilising means is preferably disposed adjacent but beyond the tip of the needle when the shield is in its extended condition so that the tip of the needle enters and moves through the sterilising means as the shield collapses under applied pressure.
The sterilising means may comprise a holder for locating a sterilising substance in the vicinity of said other end of the shield, the holder being detachable from the shield.
Advantageously the sterilising means may include a body of absorbent material for impregnation with a sterilising substance. The sterilising means may include an enclosure having an end wall which is adapted to have an integral removable portion separated therefrom by rupturing the material of the end wall in a predetermined region so as to form an aperture in the end wall through which the tip of the needle may pass. Alternatively or additionally the enclosure may have an end wall which is simply adapted to be punctured by the needle as the tip of the needle moves through the sterilising means.
The invention also provides a venting device for venting the interior of a sealed container by passing the tip of a hollow needle through a sealing portion of the container, the device comprising a needle support for holding the needle and incorporating a vent passage providing fluid communication between the hollow interior of the needle and the atmosphere, and a needle guard coupled to the needle support and extending in the direction of the length of the needle to a position beyond the tip of the needle, the needle guard permitting venting of the container by passing the tip of the needle through the sealing portion of the container whilst shielding the tip of the needle to prevent accidental needle stick when the tip of the needle is removed from the container.


REFERENCES:
patent: 4507118 (1985-03-01), Dent
patent: 4524809 (1985-06-01), Dent
patent: 4552277 (1985-11-01), Richardson et al.
patent: 5423793 (1995-06-01), Isono et al.
patent: 5776124 (1998-07-01), Wald
patent: 5785701 (1998-07-01), Sams et al.
patent: 5873872 (1999-02-01), Thibault et al.
patent: 5895383 (1999-04-01), Niedospial, Jr.

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